FDA Issues Class I Recall for Defibrillators

The Food and Drug Administration and Cardiac Science have announced a Class I recall of several types of the company’s defibrillators.

According to the FDA, the Automated External Defibrillator (AED) models were recalled because of a component that may unexpectedly fail due to a supplier manufacturing defect. This may lead to the medical device not delivering the proper defibrillation therapy to a patient and potentially cause serious adverse side effects or death. The AED’s self test may also not detect an impending failure or failure of the device.

AEDs are used during emergency situations to treat victims showing symptoms of sudden cardiac arrest who are unresponsive and not breathing.

The affected models include CardioVive, Cardiolife, and Cardiac Science Powerheart.

The FDA notes that Class I recalls are “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if you have grounds to pursue a product liability lawsuit.